ES2971315T3 - Occlusion device - Google Patents

Abstract

Provided herein is an occlusion device comprising: (a) a continuous mesh structure comprising a medial pinch point; (b) a disc-shaped elastic mesh body extending distally and outward from the medial pinch point; and (c) a compressible mesh carriage extending distally from the medial pinch point on an opposite side of the elastic mesh body of (b), wherein the compressible mesh carriage comprises a pinch point at each end of the carriage , where one of the pinch points is the medial pinch point of (a); wherein the continuous mesh structure has a first delivery form and a second deployed expandable form, and wherein the length (x) of the elastic mesh body is greater than the length (y) of the compressible mesh carriage in free air and in the unfolded form. Also provided herein is a kit comprising the occlusion device described herein and a means for delivery thereof. Methods of manufacture and use of the occlusion device described herein are also described. (Automatic translation with Google Translate, without legal value)

Description

DESCRIPTION

Occlusion device

field of invention

The occlusion device described herein is generally related to the field of occlusion devices and/or occlusion device systems and/or implantable occlusion devices and the use thereof for vessel occlusion. and/or the treatment and/or enhancement of aneurysms and/or for peripheral vascular embolization (a process well known in the art and known to involve closure of blood flow distal to a specified vascular point), for example, in the treatment and/or improvement of peripheral arterial or venous pathologies and/or any related pathology that requires vessel occlusion for treatment.

Background of the description

There is significant demand for the development of improved occlusion devices and/or systems for the treatment and/or enhancement of aneurysms. This observation is supported by the abundance and wide range of current occlusion devices and/or systems in the field of treatment of peripheral vascular embolization of aneurysms. However, there is still an unmet need to provide treatment and/or enhancement of aneurysms, particularly for neurovascular aneurysms, using occlusion devices composed of a deployable material designed to achieve greater flow interruption and greater compartmentalization to introduce stasis and/or designed in such a way that they can occlude larger and/or more irregularly shaped aneurysms.

It is well known that an aneurysm forms when a dilated part of an artery stretches and thins due to blood pressure. The weakened part of the artery forms a bulge, or bulging area, which is at risk of leaking and/or rupturing. When a neurovascular aneurysm ruptures, it causes bleeding into the compartment surrounding the brain, the subarachnoid space, causing a subarachnoid hemorrhage. Subarachnoid hemorrhage caused by a ruptured neurovascular aneurysm can lead to hemorrhagic stroke, brain damage, and death. Approximately 25 percent of all patients with a neurovascular aneurysm suffer a subarachnoid hemorrhage. Neurovascular aneurysms occur in two to five percent of the population and more commonly in women than men. It is estimated that up to 18 million people currently living in the United States will develop a neurovascular aneurysm during their lifetime. Annually, the incidence of subarachnoid hemorrhage in the United States exceeds 30,000 people. Between ten and fifteen percent of these patients die before reaching the hospital and more than 50 percent die within the first thirty days after rupture. Of those who survive, approximately half suffer some permanent neurological deficit.

Smoking, high blood pressure, head trauma, alcohol abuse, use of hormonal contraceptives, family history of brain aneurysms, and other inherited disorders such as Ehlers-Danlos syndrome (EDS), polycystic kidney disease, and Marfan syndrome possibly contribute to neurovascular aneurysms.

Most unruptured aneurysms are asymptomatic. Some people with unruptured aneurysms experience some or all of the following symptoms: peripheral vision deficits, thinking or processing problems, speech complications, perceptual problems, sudden changes in behavior, loss of balance and coordination, decreased concentration , short-term memory difficulty and fatigue. Symptoms of a ruptured neurovascular aneurysm include nausea and vomiting, neck stiffness or neck pain, blurred or double vision, pain above and behind the eye, dilated pupils, sensitivity to light, and loss of sensation. Sometimes patients who describe "the worst headache of my life" experience one of the symptoms of a ruptured neurovascular aneurysm.

Most aneurysms go unnoticed until they rupture. However, aneurysms can be discovered during routine medical exams or diagnostic procedures for other health problems. The diagnosis of a ruptured brain aneurysm is commonly made by finding signs of subarachnoid hemorrhage on a CT scan. If the CT scan is negative but a ruptured aneurysm is still suspected, a lumbar puncture is performed to look for blood in the cerebrospinal fluid (CSF) surrounding the brain and spinal cord.

To determine the exact location, size, and shape of an aneurysm, neuroradiologists use cerebral angiography or tomographic angiography. Cerebral angiography, the traditional method, involves inserting a catheter into an artery (usually in the leg) and directing it through the body's blood vessels to the artery affected by the aneurysm. A special dye, called a contrast agent, is injected into the patient's artery and its distribution is shown on X-ray projections. This method may miss some aneurysms due to overlapping structures or spasms.

Computed Tomography Angiography (CTA) is an alternative to the traditional method and can be performed without the need for arterial catheterization. This test combines a regular CT scan with the injection of contrast dye into a vein. Once injected into a vein, the dye travels to the arteries of the brain and images are created using a CT scan. These images show exactly how blood flows to the arteries of the brain. New diagnostic modalities promise to complement classical and conventional diagnostic studies with less invasive imaging techniques and possibly provide more precise three-dimensional anatomical information regarding aneurysmal pathology. Better imaging, combined with the development of improved minimally invasive treatments, will allow doctors to increasingly detect and treat more silent aneurysms before problems arise.

Various methods have been tried to treat aneurysms, with varying degrees of success. For example, open craniotomy is a procedure by which an aneurysm is located and treated extravascularly. This type of procedure has important disadvantages. For example, the patient suffers extensive trauma to the area of the aneurysm because the surgeon must cut various tissues to reach the aneurysm. In extravascular treatment of brain aneurysms, for example, the surgeon typically must remove a portion of the patient's skull and must also traumatize brain tissue to reach the aneurysm. Thus, there is a possibility of patients developing epilepsy due to the surgery.

Other techniques used in the treatment of aneurysms are performed endovascularly. These techniques typically involve attempting to shape a mass within the aneurysm sac. Typically, a microcatheter is used to access the aneurysm. The distal tip of the microcatheter is placed within the aneurysm sac, and the microcatheter is used to inject embolic material into the aneurysm sac. The embolic material includes, for example, release coils or an embolic agent, such as a liquid polymer. Injection of these types of embolic materials has disadvantages, most of which are associated with migration of embolic material out of the aneurysm and into the parent artery. This can lead to permanent and irreversible occlusion of the main artery.

For example, when detachable coils are used to occlude an aneurysm that does not have a well-defined neck zone, the detachable coils may migrate out of the aneurysm sac and enter the parent artery. Additionally, it is sometimes difficult to accurately measure how full the aneurysm sac is when the detachable coils are deployed. Therefore, there is a risk of overfilling the aneurysm, in which case the detachable coils also spill into the main artery.

Another disadvantage of detachable coils involves compaction of the coils over time. After filling the aneurysm, there is space between the coils. The continuous hemodynamic forces produced by the circulation act to compact the mass of coils, resulting in a cavity in the neck of the aneurysm. Thus, the aneurysm can be recanalized.

Migration of embolic agents is also a problem. For example, when a liquid polymer is injected into the aneurysm sac, it may migrate out of the aneurysm sac due to the hemodynamics of the system. This can also lead to irreversible occlusion of the main vessel.

Techniques have been attempted to try to overcome the disadvantages associated with the migration of embolic material to the main vessel. These techniques are, without limitation, temporary stoppage of flow and occlusion of the main vessel, and typically involve temporary occlusion of the main vessel proximal to the aneurysm, so that no blood flow occurs through the main vessel, until a gap has formed. thrombotic mass in the aneurysm sac. In theory, this helps reduce the tendency of embolic material to migrate out of the aneurysm sac. However, it has been discovered that a thrombotic mass can be dissolved by normal lysis of the blood. Furthermore, in certain cases, from the patient's risk/benefit perspective it is highly undesirable to occlude the parent vessel, even temporarily. Therefore, this technique is sometimes not available as a treatment option. Furthermore, it is now known that even occlusion of the main vessel may not prevent all migration of embolic material to the main vessel.

Another endovascular technique for treating aneurysms involves inserting a detachable balloon into the aneurysm sac using a microcatheter. The detachable balloon is then inflated using saline and/or contrast fluid. The balloon is then detached from the microcatheter and left inside the aneurysm sac in an attempt to refill the aneurysm sac. However, detachable balloons also have disadvantages and, therefore, this practice has been almost completely replaced by the current practice of deploying coils or other types of occlusion devices. For example, detachable balloons, when inflated, will typically not conform to the interior configuration of the aneurysm sac. In contrast, the detachable balloon requires that the aneurysm sac conform to the outer surface of the detachable balloon. Therefore, there is an increased risk of the detachable balloon rupturing the aneurysm sac. Additionally, detachable balloons can rupture and migrate out of the aneurysm.

Another endovascular technique for treating aneurysms includes occlusion devices having two expandable lobes and a waist, or an expandable body portion, a neck portion, and a base portion.

Still another endovascular technique for treating aneurysms includes occlusion devices for intrasaccular implantation that have a body portion designed to fill and/or expand radially into the space within the aneurysm sac.

Additional endovascular techniques are described in pending commonly held patent applications US 2015/0313605 and US 2017/0156734. Other devices are described by documents WO2006/052322, EP2596754 and US 2017/128077.

Many current occlusion devices are not designed for the treatment of large aneurysms or for aneurysms of irregular shapes and sizes, including wide and narrow neck aneurysms, lateral wall and bifurcation aneurysms, for example. Many current occlusion devices are constructed with braided or woven mesh designs, and such designs, if reconfigured for a large, irregularly shaped aneurysm, would typically use too much material. This would make it difficult for them to collapse into a low-profile, constricted delivery configuration, small enough to be administered and deployed without excessive friction on the walls of the delivery catheter or other delivery lumen. The large volume of these devices would make them cumbersome or unsuitable for intracranial administration.

Therefore, the occlusion device described herein provides innovative improvements and various advantages in the field of vascular occlusion devices because the occlusion device described herein provides treatment and/or enhancement of aneurysms and/or lumens. body, particularly for neurovascular aneurysms of large and irregular sizes, through the use of fully retrievable deployable material based on super compactable continuous mesh. The occlusion device described herein relates to a continuous configuration comprising disproportionate mesh bodies on opposite sides of a pinch point or medial marker. On one side of the pinch point or marker is located a disc-shaped mesh body that sinks inward like a cup. On the opposite side of the pinch point or marker is located a basket-shaped carriage of compressible mesh defined at both axial ends by a pinch point of the mesh or by a marker surrounded by a pinch point. This novel design achieves greater flow interruption and compartmentalization within the aneurysm or body lumen and results in greater stasis, particularly for occluding larger and more irregularly shaped aneurysms.

Compendium of invention

The present inventor has designed an intraaneurysmal occlusion device for deployment within the aneurysm sac providing treatment and/or amelioration of the aneurysm by creating flow interruption and final stasis. The occlusion device uniquely comprises a continuous mesh configuration having disproportionate mesh bodies on either side of a clamp point or medial marker that provide a continuous three-dimensional mesh network within the aneurysm for flow interruption, thrombus establishment and/or a framework for cell growth. Such an implantable occlusion device is also used for the treatment of vessel occlusion and/or peripheral vascular embolization.

Described herein is an occlusion device comprising a continuous mesh structure comprising: (a) a medial pinch point; (b) a disc-shaped elastic mesh body extending distally and outwardly from the medial pinch point, the disc-shaped body having no pinch point other than the medial pinch point; and (c) a compressible mesh carriage extending proximally from the medial pinch point on an opposite side of the elastic mesh body of (b), wherein the compressible mesh carriage comprises a pinch point at each end of the carriage, where one of the pinch points is the medial pinch point of (a); where the continuous mesh structure has a first delivery form and a second expandable deployed form, and where the length (x) of the elastic mesh body is greater than the length (y) of the compressible mesh carriage in free air and in the second expandable deployed form, wherein in the second expandable deployed form, the ends of the elastic mesh body extend distally.

In one embodiment, a marker surrounds the medial pinch point of the continuous mesh structure. In a further embodiment, the marker is radiopaque. In additional embodiments, a marker located at the non-medial end of the mesh carriage is a detachment splice for deploying the occlusion device and/or a splice connection for retrieving the occlusion device. In still other embodiments, the marker comprises or the markers comprise a rigid element, and/or the marker is (or the markers are) a solid ring(s).

In another embodiment, the continuous mesh structure expands to an unfolded shape and fills the body lumen or aneurysm with the disc-shaped elastic mesh body sunken inward into the cup-shaped configuration.

In one embodiment, the continuous mesh structure has an open mesh density greater than 40% of the open area in the mesh, for better integration into the tissue and/or better stabilization of the occlusion device.

In another embodiment, the elastic mesh body of the occlusion device is a single-layer mesh.

In another embodiment, the elastic mesh body of the occlusion device is a dual-layer or dual-layer mesh. In a further embodiment, the dual layer of mesh comprises a single layer of circumferentially folded mesh.

In another embodiment, the mesh carriage of the continuous mesh structure comprises an inner coaxial mesh carriage or inner coaxial mesh carriages. In a further embodiment, the inner coaxial mesh carriage or carriages are of a different material than its outer mesh carriage. In a further embodiment, the inner coaxial mesh carriages are two (2) or three (3) inner coaxial mesh carriages. In yet another embodiment, the inner coaxial mesh carriage(s) has a different mesh density than its outer mesh carriage.

In another embodiment, the continuous mesh structure is constructed of a super elastic material. In a further embodiment, the elastic mesh body is constructed of nitinol. In yet another embodiment, the elastic mesh body is constructed of nitinol with a DFT platinum core.

Also described herein is a kit comprising the occlusion device described herein and delivery means for deploying the occlusion device.

Additionally, methods for manufacturing the occlusion device described herein are described herein.

In other embodiments, the occlusion device of the preceding paragraphs may incorporate any of the embodiments described above or below.

The summary of the invention is not intended to define the claims nor is it intended to limit the scope of the invention in any way.

Other features and advantages of the invention will be apparent from the following drawings, detailed description and claims.

Brief description of the figures

Figure 1 illustrates a cross section of an embodiment of the occlusion device described herein showing that the length (x) of the disc-shaped elastic mesh body is greater than the length (y) of the compressible mesh carriage in fresh air.

Figure 2 illustrates an embodiment of the occlusion device described herein deployed in an aneurysm showing that the length (x) of the disc-shaped elastic mesh body is greater than the length (y) of the compressible mesh carriage in the unfolded form.

Figure 3 illustrates an embodiment of the occlusion device described herein showing that the length (x) of the disc-shaped elastic mesh body is greater than the length (y) of the free-air compressible mesh carriage.

Figure 4 illustrates the administration of one embodiment of the occlusion device described herein.

Detailed description

The present invention is illustrated in the drawings and description, in which like elements are assigned the same reference numerals. However, although particular embodiments are illustrated in the drawings, there is no intention to limit the present invention to the specific embodiment or embodiments described. Rather, the present invention is intended to cover all modifications and alternative constructions that fall within the scope of the invention. In this way, the drawings are intended to be illustrative and not restrictive.

Unless otherwise defined, all technical terms used herein have the same meaning as is customarily understood by a person of ordinary skill in the art to which this technology pertains.

Exemplary embodiments of the occlusion device described herein are depicted in Figures 1-2.

For the purposes of the occlusion device 10 described herein, the terminology "corresponds to" means that a functional and/or mechanical relationship exists between objects that correspond to each other. For example, an occlusion device management system corresponds to (or is compatible with) an occlusion device for deployment.

For purposes of the occlusion device 10 described herein, the terminology "occlusion device" means and/or may be interchangeable with terminology such as, without limitation, "device" or "occlusion device system" or "occlusion device system". occlusion" or "system" or "occlusion device implant" or "implant" or "intrasaccular implant" or "intraaneurysmal implant" and the like.

Occlusion device delivery systems are well known and readily available in the art. For example, these delivery technologies can be found, without limitation, in US Patents and Publications Nos. 4991,602; 5067489; 6833003; 2006/0167494; and 2007/0288083; Reference is made in this document to the teachings of each of them. For the purposes of the occlusion device described herein, any type of delivery means and/or delivery system and/or delivery technology and/or delivery mechanism and/or detachment (and/or attachment) means and/or o release system and/or o release technology and/or release mechanism of occlusion devices may be used and/or modified so that they are compatible (to correspond) with the occlusion device described herein. Exemplary occlusion device delivery mechanisms and/or systems include, without limitation, guide wires, pusher wires, catheters, microcatheters, and the like. Exemplary occlusion device release mechanisms include, without limitation, fluid pressure, electrolytic mechanisms, hydraulic mechanisms, locking mechanisms, and the like. In one embodiment, the occlusion device described herein is used in an electrolytic detachment method. Electrolytic release is well known in the art and can be found, for example, in US patent numbers 5122136; 5423829; 5624449; 5891 128; 6123714; 6589230; and 6620 152.

The occlusion device 10 described herein relates to a continuous mesh configuration comprising disproportionate mesh structures on opposite sides of a pinch point or marker surrounded by a medial pinch point 50. On one side of the pinch point or marker there is a 20 disc-shaped mesh body that sinks inward like a cup. The disc-shaped expansion of the mesh body 20 is a result of the body having no other pinch point or marker surrounded by a pinch point other than the pinch point or marker surrounded by a medial pinch point 50. Therefore Therefore, there is no pinch point or marker that forms the ends of the body into the shape of a sphere and, instead, the ends of the disc-shaped body 20 extend distally and outward allowing the mesh that protrusions 90 juxtapose the aneurysm dome 70, and effectively conform to the walls of the aneurysm 70 as the disc-shaped mesh body 20 sinks inward into a cup-shaped configuration. On the opposite side of the disc-shaped body 20 extending distally from the pinch point or marker surrounded by a medial pinch point 50 is located a basket-shaped compressible mesh carriage 30 defined at both axial ends by a point of pinching the mesh or by a marker surrounded by a pinch point 50, 60.

Figures 1 to 4 show a continuous mesh structure comprising a medial pinch point 50, a disc-shaped elastic mesh body 20 extending distally and outwardly from the medial pinch point 50, and a compressible mesh carriage. 30 extending proximally from the medial pinch point on an opposite side of the disc-shaped elastic mesh body 20. The compressible mesh carriage 30 comprises a pinch point at each end of the carriage, where one of the pinch points is the medial pinch point 50 of the entire continuous mesh structure. The device 10 described herein has a continuous mesh structure that is capable of having a first delivery form and a second expandable deployed form. Figure 1 shows that, in one embodiment of the device 10 described herein, the length (x) 140 of the elastic mesh body is greater than the length (y) 150 of the compressible mesh carriage 30 in free air and in the unfolded form. The continuous mesh structure of the device 10 described herein and its uniquely disproportionate mesh substructures on either side of a medial pinch point 50 promotes more effective endothelialization around the device 10 as shown when the device is in the deployed form. of Figures 2 and 4. Thus, the design of the occlusion device 10 is a continuous three-dimensional mesh network that, when deployed in an aneurysm 70 or body lumen, provides flow interruption 130, thrombus establishment 120, a framework for cell growth, and/or final blood stasis 80.

For purposes of the claimed invention, a "carriage" 30 is an axial segment of mesh between a mesh pinch point or pinch point surrounded by a mesh marker 50, 60 that causes the mesh to expand in the manner of a inflated but compressed basket 110. A "pinch point" is located at and defines the ends of an axial mesh segment. These segmented mesh carriages and pinch points are configured to be within a continuous mesh structure or network. A "pinch point" is a constrained and gathered location in the mesh structure that serves to restrict the movement of the adjacent carriage 30 at an isolated point and thereby stabilizes the carriage 30. In one embodiment of the continuous mesh structure of the device 10 described herein, the pinch points stabilize the carriage 30 relative to the disc-shaped mesh body 20 by extending proximally therefrom a pinch point located at an axial end of the carriage 30 that is located medially 50 relative to All continuous mesh structure. In a further embodiment, the continuous mesh structure comprises more than one mesh carriage 30. The number (n) of carriages 30 is as large as clinically and practically possible, and is determined by a physician in accordance with known diagnostic techniques. in advance, for the treatment of large and/or irregularly sized aneurysms, and for administration through a catheter (or microcatheter) of approximately 150 centimeters (cm). The axial length (l) of each carriage 30 may vary depending on the number (n) of carriages 30 that is considered appropriate to occlude an aneurysm 70 of a given size as long as the length (l) is sufficient to allow carriage 30 expands and compresses to a dimension (or width) greater than its original width. As accepted in the art, the diameter of said occlusion device 10 is measured in free air. The width (w) of each carriage 30 varies (in free air) from about 2 millimeters (mm) to about 50 mm to be clinically practical. When deployed, the carriage 30 is compressed such that the width (w) grows or expands to approximately a factor of two (2), such that a carriage 30 of dimension (w) is capable of growing to approximately 2 times w (or 2w). In other words, each carriage 30 is compressed like a marshmallow, causing its length (l) to reduce and its width (w) to expand. In one embodiment, in free air, each carriage 30 can be designed such that the length (l) is greater than or equal to its width (w), but in the deployed (compressed) form, w is greater than l. Such an occlusion device 10 comprising a compressible carriage 30 can be variably constructed to select the number (n) of carriages 30 as well as the corresponding length (l) and width (w) of each carriage 30 to suit to a wide range of aneurysm sizes and shapes 70 or body lumens to treat. Thus, in another embodiment, in free air, a cart 30 can be designed such that its length (l) is equal to or less than its width (w) and in the deployed (compressed) form, its width (w ) remains greater than l.

The disc-shaped elastic mesh body 20 of the continuous mesh structure extends distally from an opposite but medially located carriage pinch point 30 50 within the entire continuous mesh structure. In one embodiment, the disc-shaped mesh body 20 has an unfolded shape that sinks inward like a cup. The disc-shaped expansion of the mesh body 20 is a result of the body 20 having no other pinch point or marker surrounded by a pinch point other than the pinch point or marker surrounded by a medial pinch point 50. Therefore Therefore, there is no pinch point or marker that forms the ends of the body into the shape of a sphere or a closed and inflated shape and, instead, the ends of the disc-shaped body 20 extend distally and towards outward allowing the mesh to juxtapose the dome of the aneurysm 70 with a low profile and effectively conform to the walls of the aneurysm 70 as the disc-shaped mesh body 20 sinks inward into a cup-shaped configuration.

For the purposes of the present invention, the terminology "low profile" means that the disc-shaped mesh body 20, in free air, has a height that is approximately 10-20% of its width and, therefore, In its deployed form, the elastic mesh body 20 is flush, in a flattened manner, against the walls of the aneurysm 70. In this way, the disc-shaped body 20 of the device 10 described herein is lower and/or thinner than typical occlusion devices readily available in the art that expand to fill the aneurysm dome space (fully and/or partially with respect to the bulk of the space in the aneurysm) and that expand radially and/or or that expand spherically. In one embodiment, the disc-shaped elastic mesh body 20, in free air, has a height of approximately 12-18% of its width. In another embodiment, the disc-shaped elastic body 20, in free air, has a height of approximately 14-16% of its width. In another embodiment, the disc-shaped elastic mesh body 20, in free air, has a height of approximately 15% of its width.

In another embodiment, as shown in Figure 3, the low profile disc-shaped body 20 is a single layer of elastic mesh material. In another embodiment, as shown in Figure 1, the low profile disc-shaped body 20 is a dual (or double) layer 40 of elastic mesh material. In this way, the elastic mesh body confers its abilities to conform to the inner surface of the aneurysm walls 70 (by means of the opposing pressure of the protruding body 90 against the aneurysm walls) thus providing a stabilizing effect to anchor the device 10 in the aneurysm 70 (and thus minimizing the need for anticoagulation therapy and decreasing the risk of formation of emboli or clots that could flow deeper into the vascular tree and induce a stroke). Such a low profile configuration facilitates blood stasis 80, clot formation 120 and/or healing and/or contraction of the aneurysm 70, which is particularly advantageous if the size or mass of the aneurysm 70 is causing pain or other side effects in the patient. Furthermore, such an occlusion device 10 is well suited for adaptability to a wide range of aneurysm morphologies, particularly given that it is well known and generally accepted that aneurysms do not have a perfectly round shape.

In another embodiment, a dual-layer disc-shaped body 20 of an occlusion device 10 described herein has a wire mesh configuration that is folded circumferentially (circumferential fold line) and therefore folded. back on itself. The dual or folded layers 40 continuously intersect with the pinch point of the mesh or marker surrounded by the pinch point 50 of the compressible carriage 30. This mesh intersection of the disproportionate configurations of the device 10 is located at a medial pinch point 50 defining an axial end of the compression carriage 30 and the proximal central portion of the disc-shaped mesh body 20. This medial pinch point 50 is approximately the core of the entire continuous structure of the occlusion device 10. Without wishing to be limited by any theory, this dual or folded back layer 40 of wire mesh material triggers a mechanism of action that is believed to contribute to the improved acute thrombogenicity 120 of the device 10 in animal studies. It is believed that the localization of a small volume of clot between the dual/double layers 40, which have a large surface area contribution from the wire strands, facilitates blood stasis 80, and nucleating and stabilizing thrombus 120. In the form deployed, the disc-shaped body 20 having a folded back dual layer 40 is deeper compared to a non-deployed dual layer occlusion device, representing a width change of approximately 15%, which translates into an increase in diameter of the body when pressure is applied at the pinch point or marker 50, 60. This change in width/increase in diameter contributes to an effective anchoring effect of the deployed device 10 as blood applies pressure to the mesh body protruding body 90 distributed along the walls of the aneurysm 70. Such a configuration also provides sufficient juxtaposition of the protruding body 90 of the device 10 against the aneurysm wall 70 or vessel wall for peripheral arterial or venous occlusion. Based on animal studies, a disc-shaped body 20 provides sufficient mesh density to intensely confer stasis 80. It is further known, based on analysis of said body configuration after deployment, that the mesh/braid distribution of wire remains relatively uniform.

In another embodiment of the occlusion device described herein, a compressible axial mesh carriage 30 comprises a coaxial interior mesh carriage. Such a coaxial mesh inner carriage creates greater flow disruption 130 and greater compartmentalization 100 than an axial mesh carriage without a coaxial mesh inner carriage, thereby triggering greater stasis 80 and thrombus stabilization 120. In another embodiment , the axial carriage 30 and the coaxial carriage (or carriages) are (are) constructed of different metal mesh. In a further embodiment, the different metal mesh creates a galvanic effect that can further enhance the development of thrombus 120. In another further embodiment, the different metal mesh may be composed of a metal in a carriage that possesses radiopaque properties relative to the metal from the other cart and therefore improves the display of the device. In these embodiments, the density of the braided mesh may be the same or different in the outer axial carriages 30 and the inner coaxial carriages and the inner and outer mesh wires may have different strand numbers and wire diameters. Said coaxial carriage or carriages have variable dimensions compared to the outer axial carriage 30. For example, in one embodiment, a coaxial carriage or carriages may have between about 5% and about 95% of the dimensions of the outer axial carriage in the which the coaxial carriage or carriages are included.

In one embodiment, the device 10 is constructed of a metal braid of readily available material such as, but not limited to, nitinol (NiTi), cobalt-chromium alloy (CoCr), stainless steel, tungsten-iridium alloy, or a combination thereof. . For example, the mesh of the continuous mesh structure is woven from the most clinically relevant and practical braided mesh in a range from just 36 braids to a maximum of 144 braids. In another embodiment, the weave angle of the metallic braid construction creates the softest compressible mesh design. For example, the mesh is braided with a wire diameter of from about 0.0075 inches (0.191 mm) to about 0.005 inches (0.127 mm). Prior to the use of such an occlusion device 10, a physician or clinician determines the size and shape of the aneurysm 70 or body lumen to be treated using readily available diagnostic techniques. The physician or clinician can then best choose the occlusion device that has a dimension or dimensions that correspond to the given aneurysm or body lumen to be treated.

"Markers" 50, 60 are well known and readily available in the medical device art. In some embodiments, a marker 50, 60 consists of metallic material, often radiopaque material, and takes the configuration of a shape such as a band-shaped marker, a ring-shaped marker, a tube-shaped marker, and the like. , to surround a continuous mesh structure mesh pinch point of the occlusion device 10 described herein. Alternatively, a marker 50, 60 may consist of wire strands wound around a given pinch point and therefore surrounding it. In one embodiment, the marker or markers 50, 60 surrounding each clamp point provide a positional reference under x-ray as to where the device 10 is located on the catheter (or microcatheter) and where the device 10 is located once deployed. in an aneurysm 70 or body lumen.

In one embodiment, a marker 50, 60 such as a ring surrounds the pinch points that define each axial end of the compressible carriage 30 of the continuous mesh structure. Thus, the marker 50, 60 of the occlusion device 10 described herein is a substantially solid hoop or rigid element such as, for example, without limitation, a solid ring or band composed of materials such as, without limitation, gold, platinum, stainless steel and/or combinations thereof. In another embodiment, radiopaque materials may be used such as, for example, without limitation, gold, platinum, platinum/iridium alloy and/or combinations thereof. Such a marker 50, 60 provides positional visualization of the device during administration and placement. The markers 50, 60 are located on the occlusion device 10 surrounding pinch points located at each axial end of the carriage 30. In this way, the marker located at the distal axial end of the carriage 30 is capable of resting above or within the neck of an aneurysm 70. The solidity of the markers 50, 60 helps provide stability to the device 10 within the aneurysm 70 and prevents movement or transmission of forces through the compressible mesh carriage 30 and the shaped elastic mesh body of disc 20, thus preventing incorrect placement or accidental movement of the device 10. The markers 50, 60 are also configured with a joint to cooperate and release from / attach to a corresponding administration means such as, without limitation, a catheter of guidewire and/or pusherwire administration or technologies. It also advantageously provides complete recoverability of the device 10 described herein.

In another embodiment, the substantially solid marker 50, 60 comprises a radiopaque material (such as, without limitation, platinum, gold, platinum/iridium alloy and/or combinations thereof) to facilitate visualization of the occlusion device 10 under fluoroscopy during administration, placement and/or deployment. The marker 50, 60 comprises a proximal end and a distal end. The occlusion devices 10 described herein may be configured to incorporate the use of markers 50, 60 to influence the shape, diameter and/or curvature of the compressible carriage 30 when expansion occurs during deployment. Additionally, the marker 50, 60 can be designed with various shapes to influence the overall profile of the occlusion device 10 to ensure a proper fit of the expanded/deployed occlusion device 10 within the aneurysm sac 70.

Without wishing to be limited by any theory, this configuration of a continuous compressible mesh structure divided into disproportionate mesh segments triggers a mechanism of action that is believed to contribute to improved acute thrombogenicity 120 of the device in animal studies. It is also believed that localizing a small volume of clot between the dual layers of disc-shaped mesh 40 and the basket compartments 30, which have a large surface area contribution from the wire strands, facilitates nucleation and stabilization of the thrombus 120 in an aneurysm 70. This compartmentalization 100 of the occlusion device in its deployed form is an effective stabilization or anchoring feature of the deployed device 10 as the blood applies pressure to the mesh structure distributed over or within the neck of the aneurysm 70. Such a configuration also provides sufficient juxtaposition of the compressible device against the aneurysm wall 70 or vessel wall for peripheral arterial or venous occlusion. The device 10 described herein provides sufficient mesh density to strongly confer stasis 80 and the distribution of the mesh/wire braid remains relatively uniform upon deployment.

In another embodiment of an occlusion device described herein, the occlusion device 10 is constructed or partially constructed with a relatively uniform distribution of wire mesh yarns or braids such as, without limitation, a braided configuration of wire mesh yarns. 72 NiTi wire mesh or a combination of braided configuration of 72 NiTi and CoCr wire mesh yarns. In other embodiments, the occlusion device 10 comprises or partially comprises wire mesh yarns or braids ranging from 36 to 144 braided configurations of NiTi yarns.

For the purposes of the present invention, the term "mesh density" means the level of porosity or the ratio of metal to open area of the mesh device. Mesh density is related to the number and size of mesh openings or pores and the degree to which the pores are open or closed in situations where the opening or spacing of the pores varies between administration and delivery. deployment. Generally, a high mesh density zone of an elastic mesh material has about 70% or more metallic area and about 60% or less open area.

In one embodiment, the continuous mesh structure has or partially has an "open mesh density" for better tissue integration and/or better stabilization of the occlusion device. The open mesh density is greater than approximately 40% of the open mesh area. The open mesh density is known to have a low number, typically between approximately 40 and 80 picks per inch (PPI) (101.6 and 203.2 passes per cm) to represent the porosity of the mesh layers. . PPI is the number of repeated crossings of braided material in one linear inch. A high number of repeats (or PPI), typically between approximately 100 and 180 (254 and 457.2 passes per cm), is an indicator that the mesh is dense. A lower number of repeats (or PPI) is an indicator that the mesh is porous (open). In a further embodiment, the continuous mesh structure is constructed or partially constructed of a superelastic material, such as, without limitation, nitinol. In yet another embodiment, the structure is constructed or partially constructed of nitinol with a DFT platinum core. In other embodiments, when the structure is partially constructed of nitinol and partially constructed of DFT platinum core nitinol, the DFT platinum core nitinol is used to improve visualization of the device during deployment and implantation.

In one embodiment, as shown in Figure 4, the occlusion device 10 described herein is delivered to an aneurysm 70 or lumen by electrolytic delivery and/or deployment and/or detachment of the occlusion device 10 described herein. document through an artery and/or vessel adjacent to the aneurysm 70 or body lumen. Electrolytic removal means and methods such as those described in US Patent 5122136 are well known in the art. In one embodiment, a spirally wound core wire (or guide wire or pusher wire) of the catheter (or microcatheter) is attached within the marker 60 at its most distal end to the occlusion device 10 described herein. The curve of the spiral maintains a constant diameter (9) so as not to affect the flexibility or rigidity of the administration catheter or microcatheter or guidewire. In certain embodiments, FEP (fluorinated ethylene propylene) heat shrink tubing covers the spirally wound portion of the center wire. Numerous attachment techniques well known and readily available in the medical device art can be used to attach the distal end of the core wire within the marker 60 and to the occlusion device 10 or implant. These joining techniques include, without limitation, adhesives, laser fusion, discontinuous, spot and/or continuous laser welding. In one embodiment, an adhesive is used to bond the distal end of the center wire within the marker 60. In a further embodiment, the adhesive is an epoxy material that is cured or hardened by the application of heat or UV (ultraviolet) radiation. In a still further embodiment, the epoxy is a thermally cured two-component epoxy, such as EPO-TEK® 353ND-4 available from Epoxy Technology, Inc., 14 Fortune Drive, Billerica, Mass. Such an adhesive material or epoxy encapsulates the center wire splice within marker 60 and increases its mechanical stability.

In another embodiment, during and/or after deployment of the device 10, the spirally wound central wire releases the occlusion device 10 described herein at an electrolytic release location (or zone) located on the central wire itself. such that the central wire is cut and/or dissolved by electrolytic action at the base of the marker 60. Said action then releases and/or places the occlusion device 10 within an aneurysm 70 or vessel to be treated.

In certain embodiments, the compressible mesh structure of the occlusion device 10 described herein may be filled with an embolic material to promote coagulation and closure of the aneurysm 70.

In other embodiments, the occlusion device 10 described herein may further incorporate complementary elements and/or members such as coiling techniques, framing coils, embolic agents, additional markers, polymers, resorbent polymers and/or or a combination of these.

Elastic and compressible mesh materials for the design and/or manufacture of occlusion devices are readily available and well known to those skilled in the relevant art. Thus, elastic and compressible mesh materials are found within a wide variety of available materials such as, without limitation, nickel titanium (nitinol or also known as NiTi), stainless steel, polymers and/or combinations thereof. Exemplary known biomedical polymer families include, without limitation, polymers such as polyphosphazenes, polyanhydrides, polyacetals, poly(orthoesters), polyphosphoesters, polycaprolactones, polyurethanes, polylactides, polycarbonates, polyamides and/or a combination thereof. (See, for example, J Polym Sci B Polym Phys. Author's manuscript; available at PMC, June 15, 2012.)

In an exemplary embodiment, the elastic and compressible mesh material is formed from woven yarns of polymeric material, such as, without limitation, nylon, polypropylene or polyester. The polymer threads can be filled with a radiopaque material that allows the physician treating the aneurysm to fluoroscopically visualize the location of the device within the vasculature. Radiopaque filler materials preferably include bismuth trioxide, tungsten, titanium dioxide or barium sulfate, or radiopaque dyes such as iodine. The elastic and compressible mesh material may be formed from threads of radiopaque material. Radiopaque threads allow the doctor and/or radiologist to fluoroscopically visualize the location of the mesh, without the use of polymeric materials introduced as filler. Such radiopaque wires may be formed from materials such as, without limitation, gold, platinum, a platinum/iridium alloy and/or a combination thereof. In one embodiment, the elastic mesh material is constructed of NiTi with 10%-45% platinum core. In another embodiment, the elastic mesh material is constructed of NiTi with 10% platinum core, NiTi with 15% platinum core, NiTi with 20% platinum core or NiTi with 45% platinum core. The NiTi construction with 10% platinum core is sufficient to provide a ghost image of the occlusion device under X-ray.

Such combination wires or composite wires constructed having a radiopaque core and a non-radiopaque outer layer or sheath are readily available and well known in the medical device arts and metallic arts as DFT® wires, cables or tapes ( drawn filled tube). DFT® wire is a metal-metal composite material constructed to combine the desired physical and mechanical attributes of two or more materials in a single wire. By placing the more radiopaque, but more ductile, material in the core of the wire, the outer NiTi layer can provide the resulting composite wire with mechanical properties similar to those of a 100% NiTi wire. DFT® wires are available from Fort Wayne Metals Corp., Fort Wayne, Indiana, USA. See also, for example, the article titled Biocompatible Wire by Schaffer in Advanced Materials & Processes magazine, October 2002, pages 51- 54, to which reference is made herein.

When the compressible mesh structure is formed from radiopaque metallic threads, the threads can be covered with a polymer coating or extrusion. Coating or extrusion onto the radiopaque wire strands provides fluoroscopic visualization but also increases the resistance of the strands to bending fatigue and may also increase the lubricity of the strands. The polymer coating or extrusion, in one embodiment, is coated or treated with an agent that tends to oppose coagulation, such as heparin. These clot-resistant coatings are generally known. The polymer coating or extrusion may be any suitable extrudable polymer, or any polymer that can be applied in a thin coating, such as Teflon® or polyurethane.

In yet another embodiment, the yarns of the compressible mesh structure are formed using braided yarns of both metal and polymer. Combining metal threads with polymer threads in a braid changes the flexibility characteristics of the mesh. The force necessary to deploy and/or collapse such a mesh part is significantly reduced with respect to that necessary for a mesh part that includes only wire mesh threads. However, the radiopaque characteristics of the mesh for fluoroscopic visualization are preserved. Metallic wires that form such a device include, without limitation, stainless steel, gold, platinum, platinum/iridium, nitinol and/or combinations thereof. The polymer threads that make up the device may include nylon, polypropylene, polyester, Teflon® and/or combinations thereof. Additionally, the polymeric yarns of the mesh material can be chemically modified to make them radiopaque with known techniques such as, without limitation, using gold deposition on the polymeric yarns, or using ion beam plasma deposition of suitable metal ions on the yarns. polymeric.

The compressible mesh structure can also be formed with filaments or threads of variable diameter and/or variable flexibility. For example, wire diameters for use in the occlusion device described herein range from about 0.0075 inches to about 0.005 inches (0.191 mm to about 0.127 mm). By varying the size or flexibility of the polymer threads, the flexibility characteristics of the mesh can also be varied at the time of deployment. By varying the flexibility characteristics, both the deployed (compressed) and delivery (constrained) configuration of the elastic and compressible mesh structure can be varied or changed to substantially any desired shape.

The mesh can be formed not only of polymer threads or filaments and metal threads or filaments, but can also be formed using filaments of different polymeric materials. For example, different polymeric materials that have different flexibility characteristics can be used to form the mesh. This alters the flexibility characteristics to change the resulting configuration of the mesh structure in both the deployed position and the collapsed position. Such biomedical polymers are readily known and available in the art and can be derived from polymeric families such as, without limitation, polyphosphazenes, polyanhydrides, polyacetals, poly(orthoesters), polyphosphoesters, polycaprolactones, polyurethanes, polylactides, polycarbonates, polyamides and/or or a combination of these.

Compressible mesh materials suitable for use within mesh carriages may take the form of a flat woven sheet, a knitted sheet, or a laser cut wire mesh. In general, the material should include two or more sets of substantially parallel threads, one set of parallel threads having a pitch of between 45 degrees and 135 degrees with respect to the other set of parallel threads. In some embodiments, the two sets of parallel yarns that make up the mesh material are substantially perpendicular to each other. The overall pitch and construction of the mesh material can be optimized to meet the performance needs of the occlusion device 10.

The wire mesh strands used in the occlusion device 10 described herein should be formed of a material that is both elastic and compressible and that can be heat treated to substantially establish a desired shape. Materials believed to be suitable for this purpose include a cobalt-based low thermal expansion alloy referred to in the field of occlusion devices as Elgiloy®, high-strength, high-temperature nickel-based "superalloys" commercially available from Haynes International. under the trade name Hastelloy®, heat-treatable nickel-based alloys sold under the name Incoloy® by International Nickel, and several different grades of stainless steel. The important factor in choosing a suitable wire material is that the wires retain an adequate amount of molding surface-induced deformation (or shape memory, as described below) when subjected to a predetermined heat treatment.

A class of materials that meet these requirements are the so-called shape memory alloys. These alloys tend to have a temperature-induced phase change that will cause the material to have a preferred configuration that can be set by heating the material above a certain transition temperature to induce a change in the phase of the material. When the alloy cools, the alloy will "remember" the shape it had during heat treatment and will tend to assume that same and/or a similar configuration unless prevented from doing so.A particular shape memory alloy for use in The occlusion device 10 described herein is nitinol, an approximately stoichiometric alloy of nickel and titanium, which may also include other minor amounts of other metals to achieve the desired properties. NiTi alloys, such as nitinol, including appropriate compositions and handling requirements, are well known in the art and it is not necessary to discuss such alloys in detail here. For example, U.S. Patent Nos. 5,067,489 and 4,991,602, the teachings of which are referenced herein, discuss the use of shape memory NiTi alloys in guidewire-based technologies. These NiTi alloys are preferred, at least in part, because they are commercially available and more is known about handling such alloys than other known shape memory alloys. NiTi alloys are also very elastic. In fact, they are said to be known as "superelastic" or "pseudoelastic." This elasticity will help an occlusion device 10 as described herein return to the previous expanded configuration for deployment.

The wire strands may comprise a standard monofilament of the selected material, i.e. a standard wire material may be used. In some embodiments, a 72-strand wire configuration and/or a 72-strand braided configuration is used. In other embodiments, the occlusion device comprises wire mesh wires or braids ranging from 36 to 144 braided configurations of NiTi wires. However, if desired, individual wire strands can be formed from "cables" composed of a plurality of individual wires. For example, metal wire formed cables in which several wires are helically wound around a central wire are commercially available, and NiTi cables can be purchased that have an outer diameter of 0.003 inch (0.076 mm) or less. An advantage of certain wires is that they tend to be "softer" than monofilament wires that have the same diameter and are made of the same material. Furthermore, the use of a wire may increase the effective surface area of the wire strand, which will tend to promote thrombosis 120.

An occlusion device 10 described herein is configured with a continuous mesh structure that has a mesh density sufficient to function similarly to endothelial cell scaffold layers or compartments 100 filling a vessel or body lumen or aneurysm 70 and thereby reducing blood flow 130 by approximately 60% to trigger clot formation and/or healing of aneurysm 70 and/or final stasis 80. For purposes of the occlusion device 10 described herein, the terminology "density Mesh" means the level of porosity or the ratio of metal to open area of the mesh structure. Mesh density is related to the number and size of openings or pores in the mesh and the degree to which the pores are open or closed in situations where the opening or spacing of the pores varies between administration and delivery. deployment. Generally, a high mesh density zone of an elastic mesh material has about 40% or more metal area and about 60% or less open area.

In some embodiments, the compressible mesh structure may be uniformly formed of the same material, however, said material may have a different knitted, sewn, braided and/or cut construction.

In other embodiments, the implantable occlusion device 10 described herein can be used for the process of peripheral vascular embolization (a process well known in the art and known to involve the closure of blood flow 130 distal to a specific vascular point ), for example, in the treatment and/or improvement of peripheral arterial or venous pathologies and/or any related pathology that requires occlusion of a vessel for its treatment.

The occlusion device 10 of the invention described herein may incorporate reasonable design parameters, features, modifications, advantages and variations that are readily apparent to those skilled in the art in the field of occlusion devices.

Examples

A study protocol regarding the occlusion device 10 described herein and the rationale for the use of animals will be reviewed and approved by the Institutional Animal Care and Use Committee (IACUC) at ISIS Services and the procedures will be carried out. carried out under veterinary supervision.

The rabbit elastase-induced aneurysm model is a well-accepted and recognized model in the art for testing novel neurointerventional devices and has been the subject of several clinical publications regarding efficacy and similarity to human response. (See, for example, Alteset al. Creation of Saccular Aneurysms in the Rabbit: A Model Suitable for Testing Endovascular Devices. AJR 2000; 174: 349-354.) Therefore, it is readily accepted as a testing model by regulatory agencies. appropriate. The coagulation system of the model is very similar to that of humans. Furthermore, the model has advantageous anatomical aspects in that the diameters of the extracranial carotid arteries of rabbits are very similar to the diameter of the extracranial carotid arteries of humans. Furthermore, elastase-induced aneurysms have been shown to behave histologically similar to human aneurysms.

Various embodiments of the invention have been described. Without departing from the scope of the occlusion device 10 described herein, reasonable features, modifications, advantages and design variations of the claimed apparatus will be readily apparent to those skilled in the art by following the guidelines set forth in the detailed description above and in the realizations. Accordingly, other embodiments are within the scope of the following claims.

Claims (13)

1. An occlusion device (10) comprising a continuous mesh structure comprising: {a} a medial pinch point (50); {b} a disc-shaped elastic mesh body (20) extending distally and outwardly from the medial pinch point (50), said disc-shaped body (20) not having any other pinch point besides said medial pinch point (50); and {c} a compressible mesh carriage (30) extending proximally from the medial pinch point (50) on an opposite side of the elastic mesh body (20) of {b}, where the compressible mesh carriage (30) it comprises a pinch point (50, 60) at each end of the carriage (30), and one of the pinch points at the ends of the carriage (50, 60) is the medial pinch point (50) of {a}; where the continuous mesh structure has a first administration form and a second expandable deployed form, and where a length (x) of the elastic mesh body (20) is greater than a length (y) of the compressible mesh carriage (30) in free air and in the second expandable deployed form, characterized in that, in the second expandable deployed form, the ends of the elastic mesh body (20) extend distally and outwardly, so that the disc-shaped elastic body is sinks inward like a cup. 2. The occlusion device (10) of claim 1, wherein a marker surrounds the medial pinch point (50) of the continuous mesh structure. 3. The occlusion device (10) of claim 1 or 2, wherein a marker surrounds a non-medial pinch point (60) of the mesh carriage (30). 4. The occlusion device (10) of claim 3, wherein the marker surrounding the non-medial pinch point (60) of the mesh carriage (30) is a release joint for deploying the occlusion device (10). ) and/or a union splice to recover the occlusion device (10). 5. The occlusion device (10) of any of claims 2 to 4, wherein each marker is a solid ring or band. 6. The occlusion device (10) of any of claims 1 to 5, wherein the elastic mesh body (20) of the occlusion device (10) is a dual-layer or double-layer mesh. 7. The occlusion device (10) of claim 6, wherein the dual mesh layer comprises a single circumferentially folded mesh layer (40). 8. The occlusion device (10) of claim 7, wherein the rear-folded dual layer continuously intersects the medial pinch point (50). 9. The occlusion device (10) of any of claims 1 to 8, wherein the medial pinch point (50) defines a proximal central portion of the elastic mesh body (20). 10. The occlusion device (10) of any of claims 1 to 9, wherein the disc-shaped mesh body (20), in free air, has a height that is between 10-20% of its width. 11. A kit for the treatment and/or improvement of an aneurysm, the kit comprising: an occlusion device (10) according to any of claims 1 to 10; and a delivery system or release system corresponding to the occlusion device (10). 12. The kit of claim 11, wherein the delivery system is a microcatheter, catheter, guide wire or pusher wire. 13. The kit of claim 11 or 12, wherein the release system is an electrolytic release system.